Another Fight Over The Procedure for 103: Galderma v. Tolmar

This isn't ethics, except that you need as a litigator to be ready for the continuing disagreement at the Federal Circuit over how to address 103 in the context of litigation. Judge Prost, and others, are advocating the view that the same analysis that applies in prosecution applies in litigation: if the accused infringer shows a "prima facie case" of obviousness, the burden of production — not persuasion — shifts to the patentee to come forward with objective evidence of non-obviousness, or what judges who don't like patents call "secondary considerations." Today's split decision is here.

To me, this approach — "well, it would have been obvious, if you just look at the art, to make this" — inherently uses hindsight, becuase "to make this" is part of the equation. This could matter a lot in summary judgment or, here, bench trials…

8 thoughts on “Another Fight Over The Procedure for 103: Galderma v. Tolmar”

I did an investigation of this case, and I really don’t see what the fuss is about.

The invention was clearly disclosed in a prior patent. i.e. the scope and content of the prior art exactly covered the scope and content of the invention. The case should have been complete on summary judgment before any factual findings of secondary considerations were even considered, because the types of unexpected results were those of degree not type. The only reason this advanced beyond the summary judgment stage is because of great lawyering on Galderma’s behalf and confusion in the District of Deleware stemming from a Newman Cult that seems to think that Pharma tech is somehow niche and special.

I don’t agree that, in an issued patent, step one is always correct. It may be here — but even here it seems to shift the burden of persuasion without considering objective evidence, which builds in hindsight.

1. The claimed concentration was in a known range. This shifted the burden to the patentee.

2. The patentee showed “unexpected” results.

3. The district court agreed the results were unexpected and the majority disagreed, saying the variance in harmful effects was not large enough to be a difference in “kind.”

How does one determine whether a variance was a sufficient to be a difference in kind? Who is to make that call? And, on appeal, shouldn’t the district court findings be respected unless they are clearly erroneous?

Agreed. Don’t mess with Judge Newman on pharma patents. Or just about anything else pertaining to patent law.

As she noted in the sentence before the one you quoted, “Thus the court places new obstacles in the path of improvement patents, a change of law that is particularly pernicious in the arts where small differences may have large consequences or benefits.”

p. newman very persuasive and eloquent in dissent. she so gets it: “This rule is of further mischief now that the nation has adopted a first-to-file law with its pressures for early filing, possibly before all embodiments have been fully explored.”